India to spend $500 mn to boost capacity of drug regulators

As part of efforts to ensure that Indian pharmaceutical products meet international standards, the government is spending about $500 million to build the capacity of the country's drug regulators, a senior official said here Wednesday.

National drug controller G.N. Singh said part of the money is to be used to set up a National Drug Regulatory Academy to train professionals who test drugs in the laboratories.

"India believes in safety, efficacy and quality of drugs and is organising the system to maintain standards," Singh told media on the sidelines of the second International Exhibition for Pharma and Healthcare (iPHEX 2014) that began here Wednesday.

Singh said the government was also compiling a national pharmacopia to guide in the manufacture of drugs.

"We are also planing to harmonise the standards in all the states with a central regulatory system," he said, adding that these were all gradual investments that would also see the improvement at the sea ports and other ports to ensure that products that leave the country were of the right standard.

He said the government's zeal to bring about affordable quality drugs to the people could only materialise if the government's zero tolerance for poor quality drugs was monitored by implementing laws that punished those who violated the rules.

Sudhanshu Pandey, joint secretary in the ministry of commerce and industry, said Indian generic drugs have become globally accepted and respected, and for this reason, there was the need to send a loud message out that the government was ready to ensure that the manufacturers met the standards required of them.

Pandey said patents for about 160 drugs would be expiring soon and that would give manufacturers more opportunities but, at the same time, he cautioned that it meant that innovations in the industry will have to be transparent so that global regulators would not question the standards.

Pharmaceutical Export Council of India (Pharmexcil) says that eight out of the world's top 25 generic companies come from India.